Enforcement

HPM assists companies and individuals in responding to enforcement actions and threatened enforcement actions by state and federal prosecutors and regulators. Our attorneys have experience responding to a range of enforcement actions including:

Import Detentions

Warning Letters

Consent Decrees

Debarment proceedings initiated by FDA

Exclusion proceedings initiated by HHS

Clinical investigator disqualification proceedings

Administrative Subpoenas

Grand Jury Subpoenas

Search Warrants

Seizures

Civil Investigative Demands

Congressional Investigations

We use our in-depth understanding of laws and regulations enforced by FDA, DEA, FTC, CMS, HHS, OIG, and state and federal prosecutors to advise our clients on how to address potential enforcement actions, and to respond to and resolve them. Our related Internal Investigations and Government Investigations Practice Areas complement our Enforcement Practice.

Litigation

We regularly defend our clients against allegations of violations of law by state and federal regulators and prosecutors. Examples of our defensive litigation include:

Litigating DEA immediate suspension orders and orders to show cause

Defending Federal False Claims Act cases

Defending federal criminal charges

Litigating seizure actions

Representing witnesses in depositions, hearings, and trials

Defending State Attorney General actions

We also sue the government when it violates our clients’ rights. Our affirmative government litigation includes suits against agencies for:

Unlawful FDA decisions regarding market exclusivity under the FDC Act

Unreasonable delay in agency action

Unlawful product classification

Arbitrary and capricious or otherwise unlawful agency action, such as

Actionable FDA Warning Letters

Unlawful FDA approval of competitors’ products

Failure to approve our clients’ products

Improper imposition of import detentions

In addition, we represent our clients in litigation between private parties. We have experience as both a plaintiff and defendant in unfair competition cases under the federal Lanham Act and related state laws.